1

COMMITTEE PRINT " ! 114TH CONGRESS 2nd Session

S. PRT. 114–27

HUMAN FETAL TISSUE RESEARCH: CONTEXT AND CONTROVERSY

MAJORITY STAFF REPORT

PREPARED FOR THE USE OF THE

COMMITTEE ON THE JUDICIARY

UNITED STATES SENATE

ONE HUNDRED FOURTEENTH CONGRESS

SECOND SESSION

DECEMBER 2016

Printed for the use of the Committee on the Judiciary

HU

MA

N FETA

L TISSUE R

ESEAR

CH

: CO

NTEX

T AN

D C

ON

TRO

VER

SY

U.S. GOVERNMENT PUBLISHING OFFICE

WASHINGTON :

For sale by the Superintendent of Documents, U.S. Government Publishing OfficeInternet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

1

22–920 PDF

COMMITTEE PRINT " ! 114TH CONGRESS 2nd Session

S. PRT.

2016

114–27

HUMAN FETAL TISSUE RESEARCH: CONTEXT AND CONTROVERSY

MAJORITY STAFF REPORT

PREPARED FOR THE USE OF THE

COMMITTEE ON THE JUDICIARY

UNITED STATES SENATE

ONE HUNDRED FOURTEENTH CONGRESS

SECOND SESSION

DECEMBER 2016

Printed for the use of the Committee on the Judiciary

(II)

COMMITTEE ON THE JUDICIARY

CHUCK GRASSLEY, Iowa, Chairman ORRIN G. HATCH, Utah JEFF SESSIONS, Alabama LINDSEY GRAHAM, South Carolina JOHN CORNYN, Texas MICHAEL S. LEE, Utah TED CRUZ, Texas JEFF FLAKE, Arizona DAVID VITTER, Louisiana DAVID PERDUE, Georgia THOM TILLIS, North Carolina

PATRICK J. LEAHY, Vermont, Ranking Member

DIANNE FEINSTEIN, California CHUCK SCHUMER, New York DICK DURBIN, Illinois SHELDON WHITEHOUSE, Rhode Island AMY KLOBUCHAR, Minnesota AL FRANKEN, Minnesota CHRISTOPHER A. COONS, Delaware RICHARD BLUMENTHAL, Connecticut

KOLAN DAVIS, Chief Counsel and Staff Director KRISTINE LUCIUS, Democratic Chief Counsel and Staff Director

(III)

C O N T E N T S Page

Executive Summary ................................................................................................. 1 I. The Initial Public Debate About Fetal Tissue Research ............................... 8

II. Congressional Response to the Fetal Research Debate ................................. 10 III. The Return of the Fetal Tissue Debate in the Late 1980s ........................... 12

A. The Human Fetal Tissue Transplantation Research Panel ..................... 12 B. The George H.W. Bush Administration Rejects the Panel’s

Recommendations ....................................................................................... 14 C. Congressional Efforts To Overturn the Ban and Codify the Panel’s

Recommendations ....................................................................................... 14 D. President Clinton Lifts the Ban and Congress Codifies the Panel’s

Recommendations ....................................................................................... 16 IV. The NIH Revitalization Act of 1993 ................................................................ 17

A. The Terms of 42 U.S.C. § 289g–1 ................................................................. 17 B. The Terms of 42 U.S.C. § 289g–2 ................................................................. 18 C. GAO Verification Report ............................................................................. 19 D. Proposed Modification of 42 U.S.C.§ 289g–2 To Require Reporting ........ 20

V. Media and Congressional Investigations Into Violations of 42 U.S.C.§289g–2 in the Year 2000 ......................................................................................... 22

A. Call for Congressional Investigation .......................................................... 22 B. 20/20 Hidden-Camera Fetal Tissue Investigation ................................... 22 C. Hearing by the House Subcommittee on Health ....................................... 23 D. Another Proposed Modification of 42 U.S.C. § 289g–2 To Require

Reporting ..................................................................................................... 26 E. 2000 GAO Report on Fetal Tissue Research ............................................. 26 F. Summary ...................................................................................................... 27

VI. The Recent Controversy ................................................................................... 28 A. The Scope of the Committee’s Investigation ............................................. 29

1. Laws Potentially Violated or in Need of Modification .......................... 29 2. Parties Involved ....................................................................................... 29

B. Advanced Bioscience Resources, Inc. ......................................................... 30 1. Contracts With Planned Parenthood Affiliates ..................................... 31 2. ABR’s Fetal Tissue Technicians ............................................................. 33 3. Contracts With ABR’s Customers .......................................................... 34 4. Fetal Tissue Transaction Examples ....................................................... 35 5. ABR’s Purported Cost Justification ........................................................ 38

C. StemExpress, LLC ....................................................................................... 39 1. Contracts With Planned Parenthood Affiliates ..................................... 40 2. StemExpress’s Payments to Its Technicians ......................................... 41 3. Example of a StemExpress Fetal Tissue Transaction .......................... 42 4. StemExpress’s Purported Cost Justification ......................................... 42

D. Novogenix Laboratories, LLC ..................................................................... 43 E. Planned Parenthood .................................................................................... 44

1. PPFA’s 2001 Fetal Tissue Policy ............................................................ 46 2. Developments in 2011 ............................................................................. 47 3. PPFA Stops Monitoring Affiliate Fetal Tissue Programs in Accreditation Reviews .................................................................................. 48 4. Policy Changes in May 2015 ................................................................... 50 5. Planned Parenthood’s Post Hoc Cost Calculations Created in Response to the Committee’s Inquiry .......................................................... 51

F. Continued Lack of Oversight and Enforcement ........................................ 53 VII. Conclusion ........................................................................................................ 54 Note Regarding Exhibits ......................................................................................... 64 Combined Exhibits .................................................................................................. 65 Appendix I ................................................................................................................ 308 Appendix II ............................................................................................................... 403 Appendix III ............................................................................................................. 459

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

59

60

61

62

63